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510(k) K112562

BAL CATH BRONCHIAL ASPIRATE SAMPLING CATHETER by Kimberly-Clark — Product Code OYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2011
Date Received
September 26, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Non-Bronchoscopic Bronchoalveolar Lavage Catheter
Device Class
Class I
Regulation Number
868.6810
Review Panel
AN
Submission Type

To perform non-bronchoscopic bronchoalveolar lavage (bal) in adult patients undergoing mechanical ventilation.

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